Topic outline

  • Well come to Pharmaceutical Technology -III



    • Instructor Information

      Instructor Name        : Md. Mizanur Rahman

      Designation                : Assistant Professor

      Contact No.                : 01304728507, 01556346870

      Email                           : mizanur.ph@diu.edu.bd 

      		                                    



    • Join to attend Class : 23-A                       Recorded Video

      Restricted Not available unless: You belong to Batch-23A (Spring 23)


    • Join to attend Class : 23-B                       Recorded Video

      Restricted Not available unless: You belong to Batch-23B (Spring23)


    • Join to attend Class : 23 -C                       Recorded Video

      Restricted Not available unless: You belong to Batch-23C (Spring23)

  • Weekly Forum Discussion

    • Weekly Forum Discussion
      Due: Saturday, 21 January 2023, 9:36 PM
      View Make forum posts: 1

      • You all are advised to keep notes and ask questions in this form.
      • You can chat/talk/share knowledge freely in this section.
      • Hope you all will help each other and make it fruitful.

  • Course Instructions:

    • All the students registered for this course have to enroll in Moodle
    • Students can find all the course materials from Moodle.
    • All the students have to submit the soft copy of their "Assignment" in Moodle under assignment section created here and for this they will be graded here.
    • One discussion or feedback forum is created under each of the lecture Students have to give their feedback on these forum and marks will be given for their feedback
    • Any announcement regarding the class will be posted on Moodle. So they have to keep themselves always active on Moodle.
    • All the quizzes and presentation will be held on face to face class and may be few of the class will be held on online (Moodle) and it will be announced before the class
    • The question pattern and the syllabus for the quizzes, midterm and final exam is given here under each of the section (quizzes, midterm and final)
    • There are midterm and final exam preparation forum under these sections where students can discuss with each other about their midterm and final exam syllabus, any problem regarding the exam etc.

  • Chapter-1: Parenteral Products


    Learning Outcomes:

    • Explain  Parenteral dosage form with their ingredients list
    • Illustrate  manufacturing procedure
    • Evaluate critical parameters
    • Design new formulation

     Course Content:

    Route of administration, selection of vehicles, added substances, containers, suspension and emulsion for injections, production facilities, environmental control, personnel, cleaning of containers and closures, sterilization of equipment, compounding the products, filtration of solutions, filling and sealing procedures, sterilization of products, various quality control tests for parenteral products



    • Lecture -1 : Introduction to Parenteral Products

      Learning outcome: Students will learn about

      • Sterile dosages forms
      • Merits and de-merits of Parenteral Products.
      • General requirements of Parenteral Products.
      • Route of Administration & Classification of Parenteral Products.

    • Lecture-2: Formulation Design

      Learning outcome: Students will learn about

      • Preformulation studies required to design a parenteral products
      • API
      • Vehicles selection


    • Lecture-3: Excipients for Parenteral

      Learning outcome: Students will learn about

      • Exicipients needed for manufacturing of Parenterals 
      • properties of exicipients, 
      • percentages  of exicipients
      • Common examples of exicipients


    • Lecture-4: Manufacturing Process of Parenteral

      Learning outcome: Students will learn about

      Steps of  Manufacturing Process of Parenteral dosage form

      • Planning and preparation 
      • Compounding the product
      • Filtration of solution
      • Filling
      • Sealing

    • Lecture -5 & 6 : Sterilization & Packaging of Parenteral

      Learning outcome: Students will able to learn about 

      • Sterilization process, 
      • Most effective process 
      • Packaging guideline 
      • Packaging technology of Parenteral

    • Lecture -7 : Different Sterile Products

      Learning outcome:  Student will able to learn about 

      • Different type of Sterile Products 
      • IV admixture
      • TPN
      • Dialysis Fluid
      • Irrigating solution
      • Radio-pharmaceuticals

  • Chapter-2:Design and operation of clean rooms

    Learning Outcomes:

    • Explain the importance of a clean room
    • List the component of HVAC system
    • Classify clean room
    • Describe the qualifying parameters
    • Evaluate the best clean room
    • Construct a clean room 

    Course Content:

    Source of contamination, classification of clean rooms, airflow systems-conventional flow, unidirectional flow, laminar, airflow units; air filtration mechanisms, fibrous filters and HEPA filters, temperature and humidity control, building, construction and use, personnel, protective clothing,  cleaning and disinfection, commissioning tests  of clean and aseptic rooms, routine monitoring tests, the operation of clean and aseptic rooms, key factors in clean room operations.


    • Lecture-1: Introduction to Clean Room Technology

      Learning outcome: From this lecture student will get knowledge about

      • General idea of Clean room 
      • Features
      • Importance 
      • consideration for design


    • Lecture-2: Design of Clean Room

      Learning outcome: From this lecture student will get knowledge about

      • How to design a Clean Room, 
      • Configure a clean room, 
      • Material of construction of a clean room

  • Chapter-3: Aerosol Science and Technology


    Learning Outcomes:

    • Explain  Aerosol dosage form with their ingredients list
    • Illustrate  manufacturing procedure
    • Compare best technique
    • Find out best formulation
    • Create new formulation

    Course Content

    Definition and classification of aerosols, propellants for aerosol manufacturing, components of aerosol formulations, containers and valves for aerosols, metered dose delivery of aerosols, manufacturing of aerosols, testing and quality assurance of aerosols.



    • Lecture-1 : Introduction of Aerosol Science

      Learning outcome: From this student will get knowledge about

      • Basics of aerosol
      • Merits and demerits
      • Types
      • Commonly used drug in aerosol

    • Lecture-2 : Components of Aerosol

      Learning outcome: From this lecture student will get knowledge about

      Components of aerosol

      • Propellant
      • Container
      • Drug concentrate

    • Lecture-3 : Manufacturing of Aerosol

      Learning outcome: From this lecture student will get knowledge about

      • Manufacturing process
      • Pressure Filling Process
      •  Cold Filling Process
      • Compressed Gas Filling Process

  • Chapter-4: Design and evaluation of ophthalmic pharmaceutical products


    Learning Outcomes:

    • Describe  ophthalmic products with their ingredients list
    • Illustrate different procedure
    • Compare best technique
    • Find out best formulation
    • Develop new formulation

     Course Content

    Anatomy of the eye and adnexa, pharmacology and therapeutics of ophthalmic medication, general safety considerations, absorption of drugs in the eye; formulation of eye drops, eye lotions, eye ointments: preparation, sterilizing, packaging; contact lens care products



    • Lecture-I : Introduction of Ophthalmic Products

      Learning outcome: Students will learn about

      • Introduction
      • General requirements
      • Types
      • Guide to use

    • Lecture-II : Formulation

      Learning outcome: Students will learn about

      • Ingredients
      • Formulation design
      • Process of manufacturing

  • Chapter-5: Pilot plant study and scale-up techniques


    Learning Outcomes:

    • Explain  Pilot plant and scale-up techniques
    • Illustrate  general consideration
    • Identify critical parameters for all dosages form
    • Design new formulation

     Course Content

    Introduction, selected factors to be considered during development, types of organizational structures responsible for pilot operations, educational backgrounds of pilot plant personnel, pilot plant design for tablet development, use of the pilot plant scale-up to select the optimal procedure, problems caused by a change in  excipient supplier, process variables and measures to overcome.


    • Lecture : Pilot Plant

      Learning outcome: Students will learn about

      • Basics 
      • Importance
      • General considerations
      • Critical parameters of different dosage form
      • PO/MO, BMR, SOP, STP

  • Chapter-6: Packaging technology


    Learning Outcomes:

    • Describe types, importance, characteristics of packaging materials
    • Illustrate different procedure of packaging
    • Compare best technique
    • Design new packaging materials 

    Course Content

    Types of containers, materials used, closures, unit dose packaging, strip packaging materials, packaging of solid, parenterals and ophthalmic dosage forms, packaging of other dosage forms, stability aspects of packaging.



    • Lecture on Packaging Technology

      Learning outcome: Students will learn about

      Importance
      • Criteria
      • FDA, BP, USP guideline 
      • Different Packaging materials
      • Process of Packaging technology
      • Evaluation of Packaging materials

  • Assignments : Over view of a Pharma Industry


  • Mid-term Exam: Spring 2022


    • Final Exam : Spring 2022


      • Topic 14